PHARMACY

Prime Therapeutics president, CEO to deliver keynote address at Therigy event

BY Alaric DeArment

ST. PAUL, Minn. — The leader of pharmacy benefit manager Prime Therapeutics will be the keynote speaker at a specialty pharmacy conference Thursday.

Prime said president and CEO Eric Elliott would deliver the keynote speech, titled "Specialty Pharmacy Benefit – The Employer’s Perspective" at the first annual Therigy Specialty Pharmacy Leadership Congress in Orlando, Fla.

"It is vital to have a clear view into all components of specialty drug management and to be able to manage the constantly moving parts that play into it," Elliott said. "We need to connect to and coordinate with the health plan, the provider and the patient across the entire care continuum. In this way, we can close gaps in care that sometimes surface due to the complex nature of specialty management and the fact that several doctors and specialists may be involved in the patient’s overall care."


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PHARMACY

FDA declines approval of United Therapeutics PAH drug

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

The drug maker said it received a complete response letter from the agency for its application for a tablet formulation of the drug treprostinil. The company already markets the drug in injectable and inhaled formulations for pulmonary arterial hypertension, or PAH, a condition that causes high blood pressure in the arteries of the lungs.

The FDA issues a complete response letter when it has finished reviewing a regulatory application for a drug, but questions remain that preclude approval. The FDA’s letter called into question the importance of a measure of efficacy called "6-minute walk distance," or 6MWD, and also raised concerns about the inability to show a significant effect on 6MWD in one of the clinical trials and the inability to show an improvement in time to clinical worsening.

"We will continue using our best efforts to gain approval of oral treprostinil, and we will focus on doing so within the next four years," United chairman and CEO Martine Rothblatt said. "We will convene with our experts over the next several weeks to decide which of several paths forward to pursue."


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FDA approves Par leukemia drug

BY Alaric DeArment

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

Par said Thursday that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.

The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.


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